CLASS III ONGOING Drug recall · Reported 22 Apr 2026 · FDA Enforcement Report
Magnesium Chloride, 6-Hydrate, Crystal recalled
Avantor Performance Materials is recalling Magnesium Chloride, 6-Hydrate, Crystal per, Bulk active pharmaceutical ingredient (API), distributed nationwide in the US. The recall was initiated on 31 Mar 2026 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0488-2026
- FDA event ID
- 98689
- Recalling firm
- Avantor Performance Materials, Paris, KY
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 31 Mar 2026
- FDA classified
- 22 Apr 2026
- Reported
- 22 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 31 Mar 2026 | Recall initiated by company | |
| 22 Apr 2026 | Classified by FDA | +22 days |
| 22 Apr 2026 | Published in enforcement report | +0 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent drug
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC, 100 Matsonford Road, Suite 200, Radnor, PA 19087, NDC 10106-2448-1
Where it was distributed
Nationwide in the USA, Belgium and France
Questions about this recall
Is Magnesium Chloride, 6-Hydrate, Crystal per, Bulk active pharmaceutical ingredient (API) recalled?
Yes. Avantor Performance Materials recalled Magnesium Chloride, 6-Hydrate, Crystal per, Bulk active pharmaceutical ingredient (API) on 31 Mar 2026. The recall is Class III and its status is Ongoing. Recall number D-0488-2026.
Why was it recalled?
Subpotent drug
Which lots are affected?
Lot 23G3161005, Exp 9/21/2027
Where was it sold?
Nationwide in the USA, Belgium and France
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Avantor Performance Materials
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Potassium Phosphate, Monobasic, Crystal, NF recalled | Avantor Performance Materials | Foreign Material | Nationwide |
| Drug | CLASS III | Magnesium Sulfate 7-Hydrate recalled by Avantor Performance Materials | Avantor Performance Materials | Potency & Assay | CA, IL, NC |